An official website of the United States government Here's how you know

The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

New Drug Application (NDA): 205437
Company: AMGEN INC

Products on NDA 205437

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
OTEZLA	APREMILAST	10MG	TABLET;ORAL	Prescription	AB	Yes	No
OTEZLA	APREMILAST	20MG	TABLET;ORAL	Prescription	AB	Yes	No
OTEZLA	APREMILAST	30MG	TABLET;ORAL	Prescription	AB	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 205437

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/21/2014	ORIG-1	Approval	Type 1 - New Molecular Entity	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/205437s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/205437Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/205437Orig1s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/20/2023	SUPPL-12	Efficacy-Labeling Change With Clinical Data	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/205437s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/205437Orig1s012ltr.pdf
12/20/2021	SUPPL-11	Efficacy-New Indication	Label (PDF) Letter (PDF) Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/205437s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/205437Orig1s011ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2023/205437Orig1s011.pdf
04/10/2020	SUPPL-8	Efficacy-New Indication	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/205437Orig1s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/205437Orig1s008ltr.pdf
07/19/2019	SUPPL-7	Efficacy-New Indication	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/205437Orig1s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/205437Orig1s007ltr.pdf
06/29/2017	SUPPL-6	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/205437s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/205437Orig1s006ltr.pdf
12/21/2015	SUPPL-5	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/205437s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/205437Orig1s005ltr.pdf
04/27/2015	SUPPL-4	Manufacturing (CMC)		Label is not available on this site.
09/19/2014	SUPPL-3	Manufacturing (CMC)		Label is not available on this site.
07/28/2014	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.
07/22/2014	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.

Labels for NDA 205437

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/20/2023	SUPPL-12	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/205437s012lbl.pdf
12/20/2021	SUPPL-11	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/205437s011lbl.pdf
04/10/2020	SUPPL-8	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/205437Orig1s008lbl.pdf
07/19/2019	SUPPL-7	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/205437Orig1s007lbl.pdf
06/29/2017	SUPPL-6	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/205437s006lbl.pdf
12/21/2015	SUPPL-5	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/205437s005lbl.pdf
03/21/2014	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/205437s000lbl.pdf

Therapeutic Equivalents for NDA 205437

OTEZLA

TABLET;ORAL; 10MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
APREMILAST	APREMILAST	10MG	TABLET;ORAL	Prescription	No	AB	211761	ALKEM LABS LTD
APREMILAST	APREMILAST	10MG	TABLET;ORAL	Prescription	No	AB	211878	ANNORA
APREMILAST	APREMILAST	10MG	TABLET;ORAL	Prescription	No	AB	211674	GLENMARK PHARMS LTD
APREMILAST	APREMILAST	10MG	TABLET;ORAL	Prescription	No	AB	211734	MANKIND PHARMA
APREMILAST	APREMILAST	10MG	TABLET;ORAL	Prescription	No	AB	211774	SHILPA
OTEZLA	APREMILAST	10MG	TABLET;ORAL	Prescription	Yes	AB	205437	AMGEN INC

TABLET;ORAL; 20MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
APREMILAST	APREMILAST	20MG	TABLET;ORAL	Prescription	No	AB	211761	ALKEM LABS LTD
APREMILAST	APREMILAST	20MG	TABLET;ORAL	Prescription	No	AB	211878	ANNORA
APREMILAST	APREMILAST	20MG	TABLET;ORAL	Prescription	No	AB	211674	GLENMARK PHARMS LTD
APREMILAST	APREMILAST	20MG	TABLET;ORAL	Prescription	No	AB	211734	MANKIND PHARMA
APREMILAST	APREMILAST	20MG	TABLET;ORAL	Prescription	No	AB	211774	SHILPA
OTEZLA	APREMILAST	20MG	TABLET;ORAL	Prescription	Yes	AB	205437	AMGEN INC

TABLET;ORAL; 30MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
APREMILAST	APREMILAST	30MG	TABLET;ORAL	Prescription	No	AB	211761	ALKEM LABS LTD
APREMILAST	APREMILAST	30MG	TABLET;ORAL	Prescription	No	AB	211878	ANNORA
APREMILAST	APREMILAST	30MG	TABLET;ORAL	Prescription	No	AB	211674	GLENMARK PHARMS LTD
APREMILAST	APREMILAST	30MG	TABLET;ORAL	Prescription	No	AB	211734	MANKIND PHARMA
APREMILAST	APREMILAST	30MG	TABLET;ORAL	Prescription	No	AB	211774	SHILPA
OTEZLA	APREMILAST	30MG	TABLET;ORAL	Prescription	Yes	AB	205437	AMGEN INC

Top